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Status unknownNCT04419012POL-AFUpdated Jul 29, 2020

Polish Atrial Fibrillation (POL-AF) Registry

An observational study in Atrial Fibrillation, sponsored by Jan Kochanowski University. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-29.

Sponsored by Jan Kochanowski University · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
18 Years and older
Sex
All
01

Study summary

Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients with atrial fibrillation (AF).

Read the detailed description

Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular mortality. An important element of management of patients with AF is anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) are two main drugs groups used in thromboembolic events prevention.

Primary objective of the study is to assess the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.

Secondary objective of the study are as follows: assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients and assesment of the number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc score.

The POL-AF Registry is a multicenter prospective analysis of hospital records of patients with AF managed in ten cardiology centers.

Collected data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, laboratory tests, echocardiographic parameters and concomitant medications.

Each patient will be evaluated regarding to common scales assessing risk of thromboembolic (CHA2DS2-VASc) and bleeding (HAS-BLED, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for AF treatment) events.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial fibrillation
  • anticoagulant treatment
  • apixaban
  • dabigatran
  • rivaroxaban
  • vitamin K antagonist
  • stroke prevention
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Jan Kochanowski University is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with AF hospitalized in a participating center during study period.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with AF hospitalized in a participating center during study period

Exclusion criteria

Exclusion Criteria:

  • hospitalisation for atrial fibrillation ablation
  • death during hospitalization
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Patients with AF treated with VKA

    Other: observation

  • Patients with AF treated with NOAC

    Other: observation

Interventions

  • Otherobservation

    observation

06

What researchers measure

Primary outcomes

  1. Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.

    Compared data will include: frequency of VKAs vs NOACs prescriptions.

    Time frame: Through the study completion, an average of 2 months.

Secondary outcomes

  1. Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.

    Compared data will include: demographics, type of AF, medical history, baseline characteristics and concomitant medications.

    Time frame: Through the study completion, an average of 2 months.

  2. Number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc (heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex) score.

    The CHA2DS2-VAS score includes the following factors: heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex. According to the CHA2DS2-VAS score, high thromboembolic risk means 2 points in men, 3 points in women. Data on the components of CHA2DS2-VASC are obtained from medical records.

    Time frame: Through the study completion, an average of 2 months.

07

Study locations

1 site
  • Iwona Gorczyca
    Kielce, 25-525, Poland
08

References and documents

Publications

  • Uzieblo-Zyczkowska B, Krzesinski P, Maciorowska M, Gorczyca I, Jelonek O, Wojcik M, Blaszczyk R, Kaplon-Cieslicka A, Gawalko M, Tokarek T, Rajtar-Salwa R, Bil J, Wojewodzki M, Szpotowicz A, Krzciuk M, Bednarski J, Bakula-Ostalska E, Tomaszuk-Kazberuk A, Szyszkowska A, Welnicki M, Mamcarz A, Wozakowska-Kaplon B. Antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, including compliance with current guidelines-data from the POLish Atrial Fibrillation (POL-AF) Registry. Cardiovasc Diagn Ther. 2021 Feb;11(1):14-27. doi: 10.21037/cdt-20-839. PubMed 33708474 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04419012
Lead sponsor
Jan Kochanowski University
Responsible party
Iwona Gorczyca (MD, PhD, Principal Investigator, Jan Kochanowski University) — Principal investigator
First posted
Jun 5, 2020
Start date
Jan 6, 2019
Primary completion
Jun 30, 2020
Completion
Dec 31, 2020 (estimated)
Last update
Jul 29, 2020

Study contacts

Iwona Gorczyca, Md,PhD
principal investigator · Collegium Medicum, Jan Kochanowski University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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